ANNAPOLIS, Md., April 13, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) announced today that it has completed dosing in a U.S. Phase I clinical trial of its fully human anti-toxin monoclonal antibody, Valortim®, being developed for the prevention and treatment of inhalational anthrax.
The randomized, placebo-controlled, double-blind Phase I clinical trial was designed to evaluate single escalating doses of 1, 5, or 10 mg/kg of Valortim® (or placebo) administered intravenously over a 120 minute infusion period. A total of 28 participants, all healthy male and female volunteers between the ages of 18 and 60 years, were enrolled in the study.
"We have completed dosing of all 28 subjects and are pleased to report that no infusion-related adverse reactions have been observed in the current Phase I trial. We anticipate that safety follow-up will be completed in the third quarter of 2011 with final unblinded results available later in the year," remarked Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer.
"This represents an important step in the development of Valortim®, which is being developed to meet the criteria for stockpiling in the U.S. Strategic National Stockpile," continued Dr. Fuerst. "In preclinical animal studies Valortim® has been shown to protect both rabbits and monkeys against the lethal effects of anthrax infection when administered at the time of exposure, at doses as low as 1.0 mg/kg. When administered to rabbits after the development of symptoms, Valortim® also improved survival as late as 48 hours post-exposure as compared to control animals. We look forward to completing the Phase I clinical trial, which will provide important information about the IV dosing schedule for Valortim® in humans."
The Valortim® project has been conducted with support from the National Institute of Allergy and Infectious Diseases, National Institutes of Health and the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSN272200700033C, and is being co-developed with Bristol-Myers Squibb.
About PharmAthene, Inc.
PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:
- SparVax™ – second generation recombinant protective antigen (rPA) anthrax vaccine
- Valortim® – fully human monoclonal antibody for the prevention and treatment of anthrax infection
- rBChE (recombinant butyrylcholinesterase) – a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve agents and pesticides
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Except for the historical information presented herein, matters discussed may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; "should"; "will"; "project"; "potential"; or similar statements are forward-looking statements. PharmAthene disclaims any intent or obligation to update these forward-looking statements other than as required by law. Risks and uncertainties include risk associated with the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates, unexpected funding delays and/or reductions or elimination of U.S. government funding for one or more of the Company's development programs, the award of government contracts to our competitors, unforeseen safety issues, challenges related to the development, scale-up, technology transfer, and/or process validation of manufacturing processes for our product candidates, unexpected determinations that these product candidates prove not to be effective and/or capable of being marketed as products, challenges related to the implementation of our NYSE Amex compliance plan, as well as risks detailed from time to time in PharmAthene's Forms 10-K and 10-Q under the caption "Risk Factors" and in its other reports filed with the U.S. Securities and Exchange Commission (the "SEC"). In particular, at this point there can be no assurance that Valortim® will be shown to be safe and effective and approved by regulatory authorities for use in humans. Copies of PharmAthene's public disclosure filings are available from its investor relations department and our website under the investor relations tab at www.PharmAthene.com.
SOURCE PharmAthene, Inc.